- Cardinal Health (Trenton, NJ)
- **_What Regulatory Affairs and Clinical Submissions contributes to Cardinal Health_** The _Manager, Regulatory Affairs ( Clinical Submissions)_ is ... or timelines. + **Leadership & Team Development** + Lead, mentor, and develop junior regulatory affairs staff, providing training and guidance on regulatory … more
- Novo Nordisk (Plainsboro, NJ)
- …This individual works cross-functionally with internal and external departments on Regulatory Affairs labeling related issues. Relationships Reports to labeling ... About the Department The Clinical , Medical and Regulatory (CMR) department...and working relationships with company stakeholders. Effective collaboration with Regulatory Affairs , CMR, Supply Chain, and HQ… more
- Novo Nordisk (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- University of Pennsylvania (Philadelphia, PA)
- …operations of clinical research proposals for their team. The Program Manager will work with Investigators and data informatics teams/programs to ensure the ... of the team's work, working closely with the CRU Regulatory coordinators to manage, review and initiate trials to...Manager for the CRU will oversee Phase I-IV clinical trials. Additional activities may include recruitment, and enrollment… more
- Novo Nordisk (Plainsboro, NJ)
- …+ Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. 30% overnight ... About the Department The Clinical , Medical and Regulatory (CMR) department...Affairs , Medical Strategy & Operations, Medical Information, Publications, Clinical Directors, HEOR Directors, Global Medical Directors, Marketing, and… more
- Sumitomo Pharma (Trenton, NJ)
- …of expiry dates and communicates changes to contract manufacturing organizations, testing laboratories, clinical sites and regulatory affairs as needed. + ... and suppliers of drug substances and drug products used for investigational clinical trials and/or commercial phases. The Senior Manager ensures compliance… more
- Edwards Lifesciences (Trenton, NJ)
- …our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for ... clinical trials with skill levels exceeding the requirements of the Associate Manager Required + Experience in clinical trial design, indication lead +… more
- Fujifilm (Trenton, NJ)
- …+ Proven track record working with Marketing, Business Development, Engineering/QA, and Regulatory Affairs . + Competitive knowledge of Medical IT and Imaging ... US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all...at least 1-2 years direct experience as a Product Manager within HCUS/MIPD + Strong understanding of clinical… more